Multicenter phase 3 trial of first-line benmelstobart plus anlotinib versus sunitinib for advanced renal cell carcinoma

The phase 3 ETER100 trial, at 37 centers in China, compared benmelstobart (a novel PD-L1 inhibitor) plus anlotinib versus sunitinib as first-line treatment for advanced clear-cell renal cell carcinoma. In the per-protocol set, the median progression-free survival was 19.0 months with benmelstobart plus anlotinib versus 11.0 months with sunitinib (HR 0.55; p<0.0001). The most common grade 3 or worse treatment-related adverse event was hypertension, occurring in 34% of the patients in the benmelstobart-anlotinib group and 21% of the patients in the anlotinib group. Grade 5 TRAEs occurred in 1% of patients with benmelstobart-anlotinib versus no patients with sunitinib. The authors conclude that benmelstobart plus anlotinib improved progression-free survival compared with sunitinib among patients with previously untreated, advanced clear-cell renal cell carcinoma.